A Randomized, Controlled, Open-Label, Multi- Center, Parallel-Group Study to Demonstrate the Efficacy and Safety of RO0503821 When Administered Subcutaneously for the Maintenance Treatment of Anemia in Patients With Chronic Kidney Disease Who Are on Dialysis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 572
- 主要终点
- Mean Change in Hemoglobin Concentration From Baseline to Evaluation Periods
研究概览
简要总结
This study will assess the efficacy and safety of subcutaneous (sc) Mircera given as maintenance treatment for renal anemia in chronic kidney disease patients on dialysis who were previously receiving sc epoetin. The anticipated time on study treatment is 1-2 years and the target sample size is 100-500 individuals.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •adult patients >=18 years of age;
- •chronic renal anemia;
- •on dialysis therapy for at least 12 weeks before screening;
- •receiving sc epoetin for at least 8 weeks before screening.
排除标准
- •women who are pregnant, breastfeeding or using unreliable birth control methods;
- •administration of another investigational drug within 4 weeks before screening, or during the study period.
研究组 & 干预措施
RO0503821 (1x/2 Weeks)
Eligible participants received RO0503821 (Mircera [methoxy polyethylene glycol-epoetin beta]) subcutaneously, once every two weeks for 52 weeks. Participants received a starting dose of RO0503821 60, 100, or 180 microgram (mcg) which was based on the epoetin dose of<8000, 8000-16000, or >16000 international units (IU)/week, administered during the week preceding the switch to the study drug.
干预措施: methoxy polyethylene glycol-epoetin beta (Mircera) (Drug)
RO0503821 (1x/4 Weeks)
Eligible participants received RO0503821 subcutaneously, once every four weeks for 52 weeks. Participants received a starting dose of RO0503821 120, 200, or 360 mcg which was based on the epoetin dose of<8000, 8000-16000, or >16000 IU/week administered during the week preceding the switch to the study drug.
干预措施: methoxy polyethylene glycol-epoetin beta (Mircera) (Drug)
Epoetin Reference
Eligible participants received their ongoing weekly subcutaneous dose of epoetin alfa or beta one, two or three times weekly for 52 weeks .
干预措施: epoetin alfa or beta (Drug)
结局指标
主要结局
Mean Change in Hemoglobin Concentration From Baseline to Evaluation Periods
时间窗: Baseline (Week -4 to Week -1) and Evaluation period (Week 29 to Week 36)
A time adjusted mean change in hemoglobin (Hb) concentration was calculated using an area under the curve (AUC) approach, for both periods separately. Change in Hb concentration between the baseline and evaluation periods was calculated by subtracting the calculated average baseline Hb value from the average evaluation period Hb value. All blood samples for Hb measurements were taken prior to study drug administration. Analysis used last observation carried forward (LOCF) for missing Hb values to correct for the impact of early dropouts. The baseline period is defined as Week -4 to Week -1. The evaluation period is defined as Week 29 to Week 36.
次要结局
- Number of Participants With Red Blood Cell Transfusions(Up to Week 36)
- Number of Participants Maintaining Average Hb Concentration During the Evaluation Period Within +-1 g/dL of Their Average Baseline Hb Concentration(Evaluation period (Week 29 to Week 36))
- Number of Participants With Any Adverse Events, Any Serious Adverse Events, and Deaths(Up to week 52)
- Change From Baseline in Systolic and Diastolic Blood Pressure at Weeks 36 and 52 in Peritoneal Dialysis Participants(From Baseline (Week -4 to Week -1) to Week 36 and Week 52)
- Number of Participants With Marked Laboratory Abnormalities(Up to week 52)
- Change From Baseline in Systolic and Diastolic Blood Pressure - at Weeks 36 and 52 in Hemodialysis Participants(From Baseline (Week -4 to Week -1) to Week 36 and Week 52)
- Change From Baseline in Pulse Rate at Weeks 36 and 52 in Hemodialysis Participants(From Baseline (Week -4 to Week -1) to Week 36 and Week 52)
- Change From Baseline in Pulse Rate - Peritoneal Dialysis Participants(From Baseline (Week -4 to Week -1) to Week 36 and Week 52)